John has over 24 years of manufacturing experience with eleven of those years in the medical device industry. Not only has John worked as a Quality Assurance Engineer for medical device organizations, but he has also been trained to audit companies based on a number of ISO/ANSI/AAMI/EN standards. Because of his extensive knowledge in this area, John was recruited as a Medical Audit Team Leader and he provides training seminars to companies and individuals.
- Final FDA guidance explains how the agency evaluates benefit and risk issues in Investigational Device Exemptions (IDE) for medical devices that require clinical trials in order to be registered.
- Final US FDA Guidance on Post-market Cybersecurity Risk Management
- ISO 13485:3026
- Due Diligence and QMS assistance
- Reasons Your 510(k) Submission Will Be Rejected (And How To Avoid Them)